On January 7, 2021 Endeavor BioMedicines, a biotechnology company developing new treatments targeting the underlying causes of pulmonary fibrosis, reported it has raised $62 million in a Series A financing (Press release, Endeavor BioMedicines, JAN 7, 2021, View Source [SID1234606755]). The round was led by Omega Funds, Longitude Capital and Endeavor’s management. Proceeds from the financing will be used to advance taladegib, an inhibitor of the Hedgehog pathway, into two Phase 2 clinical studies for the treatment of idiopathic pulmonary fibrosis (IPF) in 2021.
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"IPF is a devastating condition with an estimated mean survival of 2-5 years from time of diagnosis, and currently there are no available therapies that stop the progression of fibrosis or treat the underlying causes of the disease," said John Hood, Ph.D., co-founder, CEO and chairman of Endeavor. "Emerging preclinical and clinical evidence shows the Hedgehog signaling pathway, which is implicated in chronic wound healing, plays a critical role in IPF disease pathology. With taladegib’s impressive potency and safety profile, there is the potential to introduce an entirely new class of medicine that may be able to stop or reverse the course of this deadly disease."
Studied in 176 subjects to date, taladegib has been shown to safely and effectively inhibit the Hedgehog pathway. Endeavor intends to initiate a Phase 2 study of taladegib as a monotherapy in patients with IPF in the second quarter of 2021. Pending results from the monotherapy study, Endeavor anticipates initiating a second Phase 2 study in combination with standard of care by 2022.
"In developing a best-in-class Hedgehog inhibitor therapy and applying it in an emerging area of science, Endeavor has the potential to completely change the trajectory of IPF," said Bernard Davitian, partner at Omega Funds. "This is a testament to Endeavor’s persistence in translating promising scientific insights into real medicines that can benefit patients with significant unmet medical needs. Omega is proud to support Endeavor’s world-class team in this mission."
To meet this immense demand in the IPF patient community, Endeavor BioMedicines was co-founded by Dr. Hood, who previously founded and served as CEO of Impact Biomedicines until its acquisition by Celgene in 2018. Miguel de los Rios, Ph.D., Endeavor BioMedicine’s co-founder and chief scientific officer, previously served as CEO of Rift Biotherapeutics and brings more than 15 years of management experience in R&D leadership, business development and business strategy. Endeavor’s board of directors includes Dr. Hood, Mr. Davitian and Sandip Agarwala of Longitude Capital.
"Endeavor is built on the solid foundation required for a biotech company to thrive: stellar management with a successful track record, data-driven scientific rationale for targeting the Hedgehog pathway in IPF and a devastating disease in need of innovative options," said Sandip Agarwala, managing director of Longitude Capital. "John has assembled an incredible team driven by the noble mission to transform the IPF disease area, which has been overlooked for far too long."
TARGETING AN OVERLOOKED PATHWAY AT THE CRUX OF IPF PROGRESSION
Taladegib is a small-molecule inhibitor of the Hedgehog signaling pathway. Hedgehog inhibitors have been approved for the treatment of cancers such as basal cell carcinoma and acute myelogenous leukemia, but they have yet to be applied toward pulmonary diseases.
The Hedgehog signaling pathway is a key modulator for disease progression in IPF. Myofibroblasts – the repair cells activated by the Hedgehog pathway – become dysregulated, relentlessly remodeling lung tissue, forming fibrotic scars and contracting the lung. This tissue remodeling disorder impairs lung function in IPF patients by making the lung inelastic, smaller and with compromised tissue structure. Selectively inhibiting this pathway in lung tissue causes the myofibroblasts responsible for the disorder to become inactivated and undergo apoptosis, thereby eliminating the key cellular driver of IPF and potentially stopping or reversing the disease.
AN OPPORTUNITY TO REVERSE ONE OF THE MOST DEVASTATING PULMONARY DISEASES
There are approximately 132,000 people affected with IPF in the United States alone. IPF is characterized by fibrosis in the lungs, and this scar tissue accumulates until it reaches deadly levels. As one of the most aggressive interstitial pulmonary diseases, patients with IPF face a severely depleted quality of life. Current treatments help to slow progression, but there are none available that treat the underlying mechanisms of disease progression.